Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118352286 | 11835228 | 6 | F | 20151007 | 20160718 | 20151215 | 20160727 | EXP | 336972 | IT-ACCORD-036120 | ACCORD | 61.00 | YR | F | Y | 0.00000 | 20160727 | OT | IT | IT |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118352286 | 11835228 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 1ST CYCLE 5-FU 660 IV BOLUS AND 3900 MG IV DRIP ON 20-APR | 40743 | 530 | MG | ||||||||
| 118352286 | 11835228 | 2 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous drip | PT.RECEIVED 1ST CYCLE 300 MG IRINOTECAN ON 20-APR AND 10TH CYCLE 240 MG IRINOTECAN ON 07-OCT-2015 | Y | 79068 | 240 | MG | SOLUTION FOR INJECTION | ||||||
| 118352286 | 11835228 | 3 | SS | ZALTRAP | ZIV-AFLIBERCEPT | 1 | Intravenous drip | PT.RECEIVED 1ST CYCLE ON 20-APR AND 10TH CYCLE ON 07-OCT-2015 | 0 | 240 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 118352286 | 11835228 | 4 | SS | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | PT.RECEIVED 1ST CYCLE FOLINIC ACID 330 MG ON 20-APR AND 10TH CYCLE FOLINIC ACID 260 MG ON07-OCT-2015 | 0 | 260 | MG | ||||||||
| 118352286 | 11835228 | 5 | C | GRANULOCYTE COLONY STIMULATING | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118352286 | 11835228 | 1 | Colorectal cancer |
| 118352286 | 11835228 | 2 | Colorectal cancer |
| 118352286 | 11835228 | 3 | Colorectal cancer |
| 118352286 | 11835228 | 4 | Colorectal cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118352286 | 11835228 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118352286 | 11835228 | Cough | |
| 118352286 | 11835228 | Nasal inflammation | |
| 118352286 | 11835228 | Rhinitis | |
| 118352286 | 11835228 | Stomatitis | |
| 118352286 | 11835228 | Tracheitis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 118352286 | 11835228 | 1 | 20151007 | 0 | ||
| 118352286 | 11835228 | 2 | 20151007 | 0 | ||
| 118352286 | 11835228 | 3 | 20151007 | 0 | ||
| 118352286 | 11835228 | 4 | 20151007 | 0 | ||
| 118352286 | 11835228 | 5 | 20150625 | 20151028 | 0 |